NCT00846378

Brief Summary

The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Last Updated

February 3, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

April 16, 2008

Last Update Submit

January 31, 2014

Conditions

Acute Myocardial Infarction

Keywords

ST segment elevation myocardial infarction (STEMI)timed balloon inflationspost conditioning

Outcome Measures

Primary Outcomes (4)

  • Quantitation of infarct size will be done using a modification of University Hospital's standard Single-photon emission computed tomography (SPECT) quantitation software

    6 weeks

  • Echocardiograms will be analyzed to evaluate left ventricular function. Standard techniques will be used to quantitate ejection fraction and the percentage of left ventricular circumference that is hypokinetic or dyskinetic.

    6 weeks

  • Venous blood samples troponin, creatine phosphokinase (CPK). This will be done to follow enzyme release and washout, and area data will be available and infarct size/risk area ratios in control and post-conditioning subjects will be compared.

    baseline, every 8 hours x 3

  • ECG ST segment resolution immediate post percutaneous coronary intervention(PCI), and daily x 3.

    baseline, up to 3 days

Study Arms (2)

Post conditioning

EXPERIMENTAL

After 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. The balloon should be inflated to only occlude the coronary artery. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.

Procedure: Post conditioning

Usual Care

ACTIVE COMPARATOR

Usual care for treatment of thrombolysis in myocardial infarction (TIMI) 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.

Procedure: Usual Care for STEMI

Interventions

Post conditioningPROCEDURE

after 30 seconds of re-established coronary flow following the therapeutic balloon dilatation and deflation, the same balloon will be re-inflated for 30 seconds and then again deflated for 30 seconds. This procedure of balloon inflation/deflation will be performed a total of 3 to 4 times.

Post conditioning
Usual Care for STEMIPROCEDURE

Usual care for treatment of TIMI 0 to TIMI 1 flow in occluded infarct related artery. Usual care includes reperfusion of the artery per operator discretion, i.e. primary stenting, thrombectomy, balloon inflation/deflation without timed intervals.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI
  • Onset of symptoms within 6 hours
  • TIMI 0 to TIMI 1 flow in infarct related artery

You may not qualify if:

  • collaterals to infarct related artery
  • previous infarct in related territory
  • thrombolytics
  • cardiogenic shock
  • TIMI 2 to TIMI 3 flow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Tarek Helmy, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2008

First Posted

February 18, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2010

Last Updated

February 3, 2014

Record last verified: 2014-01

Locations

US(1)